Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Stomach Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Thoracic Neoplasms

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Passionflower

Retrospective cohort of patients that were treated in the Hôpital Européen Georges Pompidou before the creation of the care pathway unit.

All consecutive patients that meet the inclusion criterion and will begin a cancer care after the study start.

Patients from the prospective cohort will have their health care scheduled by the care pathway unit.

Care pathway unit

Virginie Bichon

A centralized unit for integrated management of care pathway in Oncology has been created. This unit settles the patients' appointments (biopsy, intravenous device, chemotherapy, imaging, oncologist...).

The aim of this study is to assess the delay between the first appointment with the oncologist and the beginning of the antitumoral treatment, and therefore evaluate the efficacy of the care pathway unit.

The second aim is to assess the satisfaction of patients and health care teams.

PASSION is a french monocentric study.

For the retrospective cohort, patient will be selected through the use of data warehouse available on the HEGP.

For the prospective cohort, patient will be included according to the selection criteria.

Each patient will be followed up during 6 month and a satisfaction questionnaire will be completed at 1 month and 4 month of the first administration of anti-tumor therapy.

For both cohort, clinical-anatomo-biological data will be collected through the use of data warehouse available on the HEGP.

Integrated Care Pathway in Oncology (PASSION)

Integrated Management of Care Pathway in Oncology. Impact on the Delay of Therapeutic Management and the Satisfaction of Patients and Carers

Satisfaction of patients with OUT-PATSAT35 questionnaire (out-patient satisfaction) : Likert type scale with 5 ordered modalities (bad to excellent), rated from 1 to 5.

Satisfaction of health care teams : qualitative questionnaire with 4 ordered modalities (very satisfied to not satisfied)

MSD France

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

Behaviors and Mental Disorders

Syndrome

Low Anterior Resection Syndrome

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Postoperative Complications

Quality of Life

During this focus group, we aim to achieve various goals:

* To gain insight into the bowel symptoms and the consequences patients experienced after treating rectal cancer
* To understand the expectations of the patients regarding an electronic bowel diary
* To determine whether the questions/items derived from the literature study for the bowel diary are clear and understandable for the patients
* To explore other relevant questions/items that should be added to the bowel diary

We will include 8-12 patients in this focus group.

In this Delphi survey, a multidisciplinary group of experts and patients will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey.

We will recruit 10-18 Delphi panelists per area of expertise. These panelists are experts with international expert recognition in treating bowel symptoms in the following health care categories (abdominal surgeons, digestive/radiation oncologists, specialized pelvic floor muscle physiotherapists, nursing specialists). In addition, we will include one group comprising 10-18 patients in the Delphi survey, ensuring a comprehensive and holistic perspective on treating bowel symptoms across various healthcare categories.

During this focus group, our objective is to ensure that both the questions and answers are meaningful.

We will include 8-12 patients in this focus group.

The participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days.

To evaluate the usability of the e-diary, a group of 10 patients will participate in the assessment using the System Usability Scale (SUS).

Furthermore we will have conversations with these patients regarding the use of the application: complexity, need for additional support, coherence of the application, user-friendliness, and the need for prior knowledge.

To evaluate the validity of the e-diary, encompassing test-retest reliability, construct validity and responsiveness, participants will be instructed to use the e-diary for two separate 7-day periods.

This bowel diary will be available on the smartphone in the form of an application.

bowel e-diary

Inge Geraerts, PhD

Liesbet Lauwereins, MSc.

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.

Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS).

Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment.

Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine

The selection of items for a comprehensive bowel diary in patients with rectal cancer is based on a literature review, a patient focus group and an international Delphi survey. The patient focus group is recorded using an audio and video recording. This recording is transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software. In this Delphi survey, a multidisciplinary group of experts will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey.

Content validation of the newly developed bowel diary will be tested during interview in the post-Delphi patient focus group. This focus group is recorded using an audio and video recording. This recording are transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software.

The participants will be asked to use a newly developed electronic bowel diary for 7 consecutive days. This bowel diary will be available on the smartphone in the form of an application. After 7 days, the usability of this e-diary will be assessed with the System Usability Scale (SUS). The SUS is a questionnaire consisting of 10 items, utilizing a 5-point Likert scale to measure users' perceived satisfaction with the system. It includes two subscales focusing on usability and learnability. Scores on the SUS range from 0 to 100, with no direct correlation to percentiles (i.e., a score of 60 does not signify a usability level of 60%). Instead, a score of 70 points or higher is commonly employed as an initial threshold indicating acceptable usability. This benchmark is derived from the overall mean of more than 200 studies covering various systems and products.

Participants will be instructed to use a newly developed electronic bowel diary via a smartphone app for seven consecutive days. The research will then conduct conversations with the participants covering aspects such as complexity, the need for additional support, application coherence, user-friendliness, pre-existing knowledge requirements, and suggestions for improvement. Audio and video recordings of these conversations will be transferred to the researcher's computer and subsequently transcribed into a Word document. The transcriptions will be analyzed using NVIVO 9 software.

For the determination of the construct validity, published literature will be used to generate hypotheses regarding bowel symptoms after RC treatment. The responses recorded in the e-diaries by participants, who diligently maintained entries for a continuous period of 7 days, will be systematically analyzed and compared against the formulated hypotheses.

Criterion validity will be measured in patients, comparing the relationship between the newly developed e-diary and an accepted current measure (e.g. LARS score). The participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days.

To investigate the test-retest reliability of the newly developed bowel e-diary, patients will have to fill out the bowel diary application twice, each time for a continuous period of 7 days, during a period when the disorder and treatment do not change (i.e., after the end of adjuvant treatment and/or after closure of an eventual temporary postoperative ileostomy).

To evaluate the responsiveness of the new bowel e-diary, which measures its ability to detect actual changes over an anticipated time frame (before and after treatment), patients scheduled for specific treatments (sacral nerve stimulation/ondansetron) will be asked to use the e-diary twice. This involves recording entries before and two weeks after the treatment, each for a continuous period of 7 days.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrated Care Pathway in Oncology (PASSION)	NCT04235556	Colon Cancer Gastric Cancer Pancreatic Canc... Thoracic Neopla... Breast Cancer Ovarian Cancer Bladder Cancer Prostate Cancer	Care pathway un...	18 Years - 80 Years	Assistance Publique - Hôpitaux de Paris
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary	NCT06274190	Rectal Cancer LARS - Low Ante...	bowel e-diary	18 Years -	KU Leuven
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary	NCT06274190	Rectal Cancer LARS - Low Ante...	bowel e-diary	18 Years -	KU Leuven

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